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# Sunovion NDA Filed for Parkinson’s Off Episodes
- URL: https://www.fdaweb.com/sunovion-nda-filed-for-parkinsons-off-episodes/
- Published: 2018-03-30T12:00:00.000Z
- Updated: 2026-09-14T23:56:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141112

Sunovion Pharmaceuticals has submitted an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patients with Parkinson’s disease. The NDA is supported by data from a pivotal, Phase 3 study, [CTH-300](http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02469090%3Fterm%3DCTH-300%26rank%3D1&esheet=51781445&newsitemid=20180330005070&lan=en-US&anchor=CTH-300&index=2&md5=8b71818e09e0cbe2dbc7dd4525b6b6b9&ref=fdaweb.com), which met its primary and key secondary endpoint. In the study, the film demonstrated superior efficacy versus placebo for the on-demand treatment of Off episodes, with the effect persisting until the last observed time point at 90 minutes, according to the company.